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The Magazine
The idea behind the IIM Digitisation Lab is to show the art of the possible in a working pharmaceutical manufacturing facility.

Cover story

The art of the possible

Next to its main campus in Stevenage, England, GSK has set the course for the future of pharmaceutical manufacturing: the IIM Digitisation Lab.

Enter the unit and a narrow, dark corridor leads  to an open space in a refurbished warehouse,  revealing an artfully decorated facility with  large screens and cubicles where teams of people are busily analyzing data. It looks a bit like Google meets life science, with a bit of Hollywood added in for effect, and it is nothing less than the future of pharmaceutical manufacturing. “We wanted to build a facility we can point to and show the art of the possible,” says Patrick Hyett, who heads GSK’s IIM digitisation project.

The building that houses the IIM Digitisation Lab project was intentionally designed by Hyett and his team to create the impression that this place is different. He says, “This is meant to resemble more a start-up firm than a branch of a global healthcare company. What we do here is aimed at rapidly seeking, incubating, and driving innovation in many areas of pharmaceutical manufacturing: we want to change the way people look at making pharmaceutical products and how they go about product development and new product introduction, as well as how they operate production facilities. We wanted to start from an empty space and take a new approach rather than take an existing space and add tools over the top of it, so that we could force people to take a new look at things.”

Making change apparent

This change is very visible in the facility’s changing room. In this space operators don overshoes, gowns, gloves, safety glasses, and hairnets before entering the clean room area within a small production unit for oral solid-dosage drugs. This routine activity usually controlled by training personnel on standard operating procedures has been transformed through interactive technologies that guide the operator through the process and provide visual and digital confirmation that each piece is donned correctly. This changes the way people think about gowning from something routine to something that is correct and standard every time. It is the kind of total rethinking of how things are done that lies at the heart of the center.

We will continue to call on our partners, including Siemens, for future strategic collaboration, and I am looking forward to seeing what else they will bring to this project.
Patrick Hyett, IIM Digitisation Lab Director, GSK

A micro “factory of the future”

In the space beyond that changing room, the IIM facility currently boasts a complete production unit for a continuous direct-compression oral solid-dosage manufacturing line, a very typical pharmaceutical process. Though comparatively simple, the facility has all the system components required for design and development, tech transfer, and new formulated product introduction.

“This is where we want to trigger another change in mind-set,” says Hyett. “In a pharmaceutical manufacturing facility, systems can be exploited to help manage operations, target operational efficiency, improve quality and compliance in the plant, and develop reliable and robust manufacturing processes for a new product. With the IIM facility, we use a range of technologies to integrate the data that are generated along the product lifecycle with the context in which they are generated, record and assemble these data automatically, and present them as meaningful information. Then we can make use of the data to improve the various processes. We can use data in the design phase to drive lineage more efficiently and build confidence in experiments, which will potentially reduce time to market as we make informed decisions based on data almost in real time. On the manufacturing floor, we can drive and build models on a unit level to optimize or adapt a process for related products, or we can develop sophisticated models for specific products. This modeling capability gives us the means to continuously test and improve all processes.”

Combining expertise

What sounds easy on paper, however, requires quite a business change, as Hyett explains: “The IIM team needed expertise in many technical areas – development and production business processes, process automation, manufacturing execution systems, IT, and data science – in order to convert what is available in terms of new technology into a solution that would address our business challenges.”

For example, one issue involved operator acceptance: “As an engineer, and especially as an automation engineer, what you think is essential information on a screen often is not what an operator needs or expects. So getting feedback from manufacturing practitioners was extremely important for us, and we have completely redesigned the user interface and what our electronic batch records look like on display systems. The core workflow engine remained, but the operation and representation of the system is all new and focuses on showing the operator only the information required to complete the current manufacturing step and to maintain situational awareness of upcoming events.”

As game-changing technology innovations are transforming other industries, a mechanism for rapid assessment of these innovations in our business is essential. Real business impact can be achieved when you bring the right technology to bear on a functional need.
Patrick Hyett

More than just a set of clever technologies

Hyett emphasizes that while the visible technology is eye-catching, there is a serious strategy behind the approach: “When we came up with the plan for the IIM proof of concept, we wanted to demonstrate that with state-of-the-art technology, we could help exploit the potential of digitisation for GSK and address many of our manufacturing challenges. It is very difficult to point to a reference facility in pharma where there is truly an end-to-end digitised model that can act as a role model for a network of manufacturing sites. While most people understand that a well-designed digital system architecture can help improve many aspects of our business, such as operational efficiency, product ­robustness, and regulatory confidence, we needed to make the required transition real to people – including having a working production unit – so they could experience physically what can be achieved and also embrace the changes and challenges associated with it. That’s why we built this facility.”

The technologies in the center are designed to provide systems that enable context-rich data acquisition and control; enforcement of sample, experiment, and batch genealogy; electronic workflow execution (e.g., elimination of paper records); and data virtualization and integration, enabling data use without manual intervention. Rather than enhance existing tools to perform these functions, the center reached out to innovators in other industries and found a new generation of tools that could help transform pharma.

Turning data into information

While the advanced models are still being developed for pharma, the center has reached out to partners like Siemens, which have helped integrate data and context in other areas with readily available solutions for data acquisition and control, manufacturing execution systems, production scheduling, and workflow execution. “One of the key learnings we gained during this project – and where the collaboration with Siemens has proven very valuable – was how we can make the data available on different levels of our organization. Ensuring ease of data use and information for management is key, and having Siemens’ industry expertise has really helped our journey to achieve this,” says Hyett.

Smart space

In this manufacturing “smart space,” created by aligning people, technology, and data, the focus is on the abstraction and presentation of data for the operators, streamlining their situational awareness during the manufacturing process and allowing the manufacturing room itself to be an equal participant in the creation of medicines, alongside the human operators themselves. Acting as a true smart space, the room identifies situations and statuses that humans cannot see or perceive at a glance, like the performance of an equipment train, stopping the process of manufacturing before mistakes are made. This then frees up humans to do what they do best: managing by exception, drawing inferences, and using their senses and intuition to make data-driven decisions.

Interactive screens and advanced communications systems are used to enable access to intuition from remote parties. “As game-changing technology innovations are transforming other industries, a mechanism for rapid assessment of these innovations in our business is essential. Real business impact can be achieved when you bring the right technology to bear on a functional need,” says Hyett. “We can get to the point where we can enable remotely located staff to work together within a manufacturing operation using high-fidelity video, screen sharing, and a secure remote user interface for shared operation control. This technology enables new forms of batch context – voice and video – and in turn the possibility of online checks and proactive ‘during-execution’ online quality support or technical support.”

This concept extends beyond the manufacturing room. In the corridor outside, display systems present a real-time picture of the manufacturing process under way at configurable levels of detail, ranging from a plantwide overview to operating instructions for tableting to trending of process parameters shown against a predictive model. In addition, the location and status of all people, equipment, and materials in the facility are available from radio-frequency identification (RFID) sensing and are used to determine the status of rooms within the facility – whether actively manufacturing, awaiting an intervention, or complete and awaiting cleaning.

Building the center

The team came up with completely new ideas in many other areas as well, also working with specialist companies in some cases. “We brought in people from the computer gaming industry, user experience designers, and IT and automation experts, and in certain areas we built our own solutions from scratch,” says Hyett. “At the same time, we needed to keep the solution as simple as possible and keep the number of applications to a minimum for delivering the desired functionality – IIM has to be manageable in an industrialization context, after all.”

When selecting partners for the project, Hyett and his team were especially looking for one thing: willingness to collaborate and learn in an open innovation set-up. “Partners like Siemens, who is also a strategic partner of GSK in manufacturing automation and thus a preferred automation supplier for GSK production and R&D sites worldwide, were brought in,” says Hyett. “They clearly recognized that, together with us, they could shape and expand their offering for the pharmaceutical industry – and this collaborative spirit is what distinguishes a strategic partner from a (preferred) supplier. Additionally, they brought in added value in terms of cross-industry know-how. When you aim to design a data-driven business process, as we do with IIM, you need extended modeling capabilities. Siemens has some advanced predictive modeling solutions for other industries, for example, models designed to streamline maintenance for wind turbines, and we might be able to adapt these for our own modeling solutions.”

The road ahead

The project team rapidly designed, built, and implemented the IIM facility, and the center is now being used to accelerate technology adoption within GSK. The IIM team is already busy with the next steps: establishing software- and system-neutral requirements as a prerequisite for strategic industrialization, working on point solutions for prioritized tasks for manufacturing sites, and refining solutions so they can be deployed as a fully digitised manufacturing process in capital investment projects. “We will continue to call on our partners, including Siemens, for future strategic collaboration, and I am looking forward to seeing what else they will bring to this project,” says Hyett. For him, IIM has already been a trigger for a mind-set shift, and not just for manufacturing: “It’s not just about technology – what is equally important is the human aspect. We have put an incredible amount of effort into creating the data architecture, but we want to road test the facility with formulation scientists, operators, schedulers, quality assurance, and many other specialists to ensure that our solutions are really giving people the information they need to do their job and make timely and informed decisions with the minimum of effort. The ability to interact with advanced technology in a simple form really makes a compelling argument. This is something that I have learned from this project: you are not just designing a machine or a control system; you are creating a user experience as well – and winning users over to your purpose is just as important as meeting the technical specifications.”

The IIM team has obviously been very successful at that. “We have excellent feedback from key stakeholders within GSK who are as thrilled by our achievements as we are. So much is possible already. All you have to do is be creative and make use of the technology that is out there,” Hyett says.

Picture credits: GSK / Tim Pope